PURPOSE: To compare the anti-inflammatory and analgesic efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with those of prednisolone acetate 1% in patients having cataract surgery. SETTING: Shawnee Mission Eye Care, Shawnee Mission, Kansas, USA. METHODS: This double-blind, randomized, single-site study comprised 59 healthy men and women with a clinical diagnosis of routine ocular cataract requiring surgical removal. All patients had extracapsular cataract extraction and posterior chamber intraocular lens implantation. After surgery, patients were randomized to receive ketorolac tromethamine 0.5% or prednisolone acetate 1%, self-instilled in the treated eye, according to the following schedule: 1 to 2 drops 4 times daily (week 1); 3 times daily (week 2); 2 times daily (week 3); once daily (week 4). Patients were examined postoperatively on days 1, 7, and 28. Intraocular anti-inflammatory efficacy was assessed by lid edema, lid injection, conjunctival injection, corneal edema, ciliary flush, and anterior chamber cells. Analgesic efficacy was assessed by patient self-rated pain severity, pain frequency, total symptom sum, and overall global improvement. RESULTS: Both treatments produced comparable reductions in intraocular inflammation and pain after cataract surgery and were well tolerated by patients. No adverse events were reported, and there were no significant changes in intraocular pressure in either group. Improvements in visual acuity were also similar in both groups. CONCLUSION:Ketorolac tromethamine 0.5% ophthalmic solution was as effective and well-tolerated as prednisolone acetate 1% solution in controlling postoperative inflammation and pain after cataract surgery.
RCT Entities:
PURPOSE: To compare the anti-inflammatory and analgesic efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with those of prednisolone acetate 1% in patients having cataract surgery. SETTING: Shawnee Mission Eye Care, Shawnee Mission, Kansas, USA. METHODS: This double-blind, randomized, single-site study comprised 59 healthy men and women with a clinical diagnosis of routine ocular cataract requiring surgical removal. All patients had extracapsular cataract extraction and posterior chamber intraocular lens implantation. After surgery, patients were randomized to receive ketorolac tromethamine 0.5% or prednisolone acetate 1%, self-instilled in the treated eye, according to the following schedule: 1 to 2 drops 4 times daily (week 1); 3 times daily (week 2); 2 times daily (week 3); once daily (week 4). Patients were examined postoperatively on days 1, 7, and 28. Intraocular anti-inflammatory efficacy was assessed by lid edema, lid injection, conjunctival injection, corneal edema, ciliary flush, and anterior chamber cells. Analgesic efficacy was assessed by patient self-rated pain severity, pain frequency, total symptom sum, and overall global improvement. RESULTS: Both treatments produced comparable reductions in intraocular inflammation and pain after cataract surgery and were well tolerated by patients. No adverse events were reported, and there were no significant changes in intraocular pressure in either group. Improvements in visual acuity were also similar in both groups. CONCLUSION:Ketorolac tromethamine 0.5% ophthalmic solution was as effective and well-tolerated as prednisolone acetate 1% solution in controlling postoperative inflammation and pain after cataract surgery.